MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number	G407212
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing ref: 3008452825-2023-00030.During a right and left atrial procedure in a patient with a congenital heart defect and junctional ectopic tachycardia, cryo ablation was performed in both the left and right atrium with a medtronic freezr.After the procedure was finished, an unknown particle was noted in the left atrium in the ultrasound imaging.The particle could be a thrombus but could not be confirmed during procedure.It was also thought to be a particle from an inserted product.In prior ultrasound imaging before the procedure the particle was clearly not visible in the patient's left atrium.The physician inspected the agilis and brk after extraction and did not notice any defect.The procedure was finished as planned and the patient was stable and sent to the icu for further observation.The particle not retrieved, as it was hoped it was a thrombus that could be heparinized.Following procedure, the patient was anticoagulated, and the particle was not visible the next day, thus the physician says it was a thrombus.The patient is stable and was dismissed from the hospital.
Additional Manufacturer Narrative
One brk transseptal needle/stylet assembly were received for evaluation.No visual anomalies were noted.No resistance or functional anomalies were noted when the returned brk needle/stylet assembly was advanced through the returned dilator/sheath assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported patient thrombus remains unknown.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Common Device Name: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16244856
• Report Number: 3008452825-2023-00031
• Device Sequence Number: 6351824
• Product Code: DRC
• UDI-Device Identifier: 05414734205191
• UDI-Public: 05414734205191
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G407212
• Device Catalogue Number: G407212
• Device Lot Number: 8505193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS NXT STEERABLE INTRODUCER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown